Phase 3
Completed N=740
VX-950-C211 - A Dosing Regimen Study (Twice Daily Versus Every 8 Hours) of Telaprevir in Treatment-naïve Participants With Genotype 1 Chronic Hepatitis C Virus Infection
Genotype 1 Chronic Hepatitis C · Treatment Naive
Source: ClinicalTrials.gov NCT01241760 ↗
Enrolled (actual)
740
Serious AEs
8.5%
Results posted
Jun 2014
Primary outcomePrimary: Percentage of Participants With Sustained Virologic Response (SVR) 12 Weeks After the Last Planned Dose of Study Drugs (SVR12 Planned) — 72.8; 74.3 percentage of participants with response
Summary
The purpose of this study is to evaluate the effectiveness of telaprevir administered twice daily versus every 8 hours in combination with Peg-IFN-alfa-2a and ribavirin in treatment-naïve participants with chronic HCV genotype 1 infection.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Percentage of Participants With Sustained Virologic Response (SVR) 12 Weeks After the Last Planned Dose of Study Drugs (SVR12 Planned) |
72.8; 74.3 | — |
| SECONDARY Percentage of Participants With Sustained Virologic Response 24 Weeks After the Last Planned Dose of Study Drugs (SVR24 Planned) |
72.8; 74.8 | — |
| SECONDARY Percentage of Participants With Sustained Virologic Response 72 Weeks After the Start of Study Medication (SVR72 Planned) |
69.0; 70.2 | — |
| SECONDARY Percentage of Participants Achieving Hepatitis C Virus (HCV) Ribonucleic Acid (RNA) Values of Less Than 25 IU/ml, Target Not Detected, at Different Time Points. |
0; 0; 67.4; 69.4; 63.1; 66.1 | — |
| SECONDARY Percentage of Participants With On-treatment Virologic Failure Which Required Them to Permanently Discontinue All Study Drugs |
9.7; 10.3 | — |
| SECONDARY Percentage of Participants Who Relapsed During Follow-up Period |
7.2; 7.7 | — |
| SECONDARY Percentage of Participants of Each IL28B Genotype Achieving Sustained Virologic Response 12 Weeks After the Last Planned Dose of Study Medication (SVR12 Planned) |
86.8; 92.4; 67.8; 67.5; 64.9; 65.5 | — |
Eligibility Criteria
Inclusion Criteria
- Patient has chronic HCV infection genotype 1 with HCV RNA level > 1,000 IU/mL
- Patients should not have had any previous treatment for hepatitis C
- Patient must have documentation of a liver biopsy within 2 years before the screening visit or the patient must agree to have a biopsy performed within the screening period
- Patients with cirrhosis should have serum alpha-fetoprotein (AFP) 50 ng/mL, absence of a mass must be demonstrated by ultrasound within the screening period
- A female patient of childbearing potential and a nonvasectomized male patient who has a female partner of childbearing potential must agree to the use of 2 effective methods of birth control from screening until 6 months (female patient) or 7 months (male patient) after the last dose of RBV.
Exclusion Criteria
- Patient is infected or co-infected with HCV of another genotype than genotype 1 and/or patient is infected with more than one genotype subtype
- Patient has a pre-existing psychiatric condition
- Patient has history of decompensated liver disease or shows evidence of significant liver disease in addition to hepatitis C
- Patient has human immunodeficiency virus (HIV) or hepatitis B virus (HBV) co-infection
- Patient has active malignant disease or history of malignant disease within the past 5 years (with the exception of treated basal cell carcinoma).
Data sourced from ClinicalTrials.gov (NCT01241760). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.